Downloads: 1
| # | Blank 1 | Frequency | Blank 2 | Frequency | |
|---|---|---|---|---|---|
| 1 | 33 | patients who are currently part of or have participated in any clinical investigation with an investigational drug within | 10 | month prior to dosing | 12 |
| 2 | 29 | participation in other studies involving investigational drug s phases | 3 | 8 | |
| 3 | 13 | participation in another clinical study with an investigational product during the last | 2 | day 1 | 2 |
| 4 | 16 | participation in any other clinical trial involving another investigational agent within 4 weeks prior to day | 2 | month | 2 |
| 5 | 46 | participation in a clinical study with an investigational product within 4 weeks prior to the start of the study treatment i . e . d1 of cycle | 2 | of the study . | 2 |
| 6 | 1 | prior participation in an investigational study drug procedure or device within 21 days of study day | 1 | . | 1 |
| 7 | 2 | current enrollment in an investigational drug or device study or participation in such a study within 30 days of cycle | 1 | day 1 . | 1 |
| 8 | 3 | use of any investigational product ip or investigational medical device within 28 days before day | 1 | of study drug | 1 |
| 9 | 4 | any other investigational agent or used an investigational device within 21 days prior to day | 1 | of protocol therapy | 1 |
| 10 | 5 | within 5 times the half life of the drug or within 3 weeks prior to study day | 1 | if the half life is not known . | 1 |
| 11 | 6 | denosumab or are only allowed if given in a stable dose and for a nonmalignant condition or received an investigational drug including investigational vaccines or used an invasive investigational medical device within 4 weeks before cycle | 1 | week 1 or current enrollment in an investigational drug or device study | 1 |
| 12 | 7 | day | 1 | month before study entry | 1 |
| 13 | 8 | current enrollment in an investigational drug or device study or participation in such a study within 4 weeks of cycle | 1 | month prior to initiation of therapy | 1 |
| 14 | 9 | prior participation in an investigational study procedure or device within 21 days of study day | 1 | portions of this trial while on mln 9708 patients may enroll in transplant and post transplant studies after consolidation 1 treatment | 1 |
| 15 | 10 | treatment with another investigational drug or device within 28 days prior to day | 1 | day 1 of the study . | 1 |
| 16 | 11 | use of investigational drug within 4 weeks of day | 1 | of the study or at least 5 half lives of the investigational agent whichever is shorter | 1 |
| 17 | 12 | participation in another clinical study involving an investigational product within | 1 | and during the study | 1 |
| 18 | 15 | within 21days of the start of this trial and throughout induction and consolidation | 1 | or lower shomcLd have occurred | 1 |
| 19 | 17 | subjects may not be receiving any other investigational agents or have participated in any other clinical trial involving another investigational agent for treatment of advanced solid tumors or lymphoma within 3 weeks prior to cycle | 1 | and during study | 1 |
| 20 | 18 | participation in any other clinical trial involving another investigational agent for the treatment of aml within 2 weeks prior to day | 1 | of cycle | 1 |
| 21 | 19 | participation in another clinical trial with drug intervention within 21 days prior to start of cycle | 1 | and 12 which are replaced by | 1 |
| 22 | 20 | prior treatment in any other clinical trial involving another investigational agent within 4 weeks prior to day 31 of the study resolution of respective adverse event to grade | 1 | for this clinical trial except for subjects entering part b who have previously received foscarnet treatment in part a of this trial . participation in a clinical trial without receiving other investigational drugs e . g . follow up phase of a trial observational study is permitted . | 1 |
| 23 | 21 | participation in another clinical trial with drug intervention within 28 days prior to start of cycle | 1 | 4 within 2 weeks before randomization in the current study | 1 |
| 24 | 23 | treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment the following exceptions are allowed r n unapproved / experimental tkis discontinued 14 days prior to cycle | 1 | 4 within 4 weeks of registering for the current study and / or during study participation . | 1 |
| 25 | 24 | treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to day | 1 | 4 before the current study begins and / or during study participation . | 1 |
| 26 | 25 | treatment with any other investigational agent or participation in another clinical trial within 28 days prior to the start of cycle | 1 | month prior to dosing except alk inhibitors | 1 |
| 27 | 26 | exclusion criteria all exclusion criteria as for part a except for inclusion criteria | 1 | NA | |
| 28 | 27 | known intolerance to pritelivir or any of the excipients and 12 . having received an investigational drug in an investigational drug trial within the last 30 days before day | 1 | NA | |
| 29 | 28 | prior participation in an investigational study within 21 days of study day | 1 | NA | |
| 30 | 32 | have participated in another therapeutic clinical trial with an investigational drug within | 1 | NA | |
| 31 | 34 | patients may not be receiving any other investigational agents if patients are currently part of or have participated in any clinical investigation with an investigational drug the last administration of the investigational study shomcLd be at least | 1 | NA | |
| 32 | 37 | patients who are currently part of or have participated in any clinical investigation with an investigational therapeutic drug within | 1 | NA | |
| 33 | 42 | are unlikely to comply with follow up visits or other study requirements patients who are currently part of or have participated in any clinical investigation with an investigational drug within | 1 | NA |