NCT03345485 · OUTCOME
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE V4.03 on Phase 1
Study of the Safety, Pharmacokinetics and Efficacy of Tinostamustine in Patients With Advanced Solid Tumors. · Source last updated 2024-10-21
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From each patient's time of first dose administration to discontinuation of study drug (at any time or D28 of the last treatment cycle), up to 6 months.
What was measured
All TEAEs was reported from the first dose of study drug through the time of study drug discontinuation (at any time or Day 28 of the last treatment Cycle). All treatment-related TEAEs was followed until resolution or stabilization. For the purpose of regulatory reporting requirements, causal relationships of definite, probable, and possible was considered treatment-related.
Number of patients experiencing treatment-related adverse events (TEAE) as assessed by CTCAE v4.03. (June 2010).
Analysis population: The safety analysis summarised TEAEs for all treated subjects using discrete summaries at the subject and event level by system organ class (SOC) and preferred term (PT). Treatment-related TEAEs were summarised similarly. TEAEs were also summarised by the grade of National Cancer Institute Common Terminology Criteria for Adverse Events. All AEs were coded using the MedDRA® version 24.0
Groups in this outcome
Tinostamustine (EDO-S101) - Phase 1 - 60mg/m2 (30 Min) Cohort 1
Patients who received Tinostamustine at 60mg/m2 (30min) on D1 and D15 of a 4-week cycle
Tinostamustine (EDO-S101) - Phase 1 - 80mg/m2 (30 Min) Cohort 2
Patients who received Tinostamustine at 80mg/m2 (30min) on D1 and D15 of a 4-week cycle
Tinostamustine (EDO-S101) - Phase 1 - 100mg/m2 (30 Min) Cohort 3
Patients who received Tinostamustine at 100mg/m2 (30min) on D1 and D15 of a 4-week cycle
Tinostamustine (EDO-S101) - Phase 1 - 60mg/m2 (60 Min) Cohort 4
Patients who received Tinostamustine at 60mg/m2 (60min) on D1 and D15 of a 4-week cycle
Tinostamustine (EDO-S101) - Phase 1 - 80mg/m2 (60 Min) Cohort 5
Patients who received Tinostamustine at 80mg/m2 (60min) on D1 and D15 of a 4-week cycle
Tinostamustine (EDO-S101) - Phase 1 - 100mg/m2 (60 Min) Cohort 6
Patients who received Tinostamustine at 100mg/m2 (60min) on D1 and D15 of a 4-week cycle
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 60mg/m2 (30 Min) Cohort 1 | 3 |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 80mg/m2 (30 Min) Cohort 2 | 3 |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 100mg/m2 (30 Min) Cohort 3 | 3 |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 60mg/m2 (60 Min) Cohort 4 | 3 |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 80mg/m2 (60 Min) Cohort 5 | 8 |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 100mg/m2 (60 Min) Cohort 6 | 2 |
|---|
Reported measurements
Investigations
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 60mg/m2 (30 Min) Cohort 1 | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 80mg/m2 (30 Min) Cohort 2 | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 100mg/m2 (30 Min) Cohort 3 | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 60mg/m2 (60 Min) Cohort 4 | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 80mg/m2 (60 Min) Cohort 5 | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 100mg/m2 (60 Min) Cohort 6 | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Gastrointestinal disorders
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 60mg/m2 (30 Min) Cohort 1 | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 80mg/m2 (30 Min) Cohort 2 | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 100mg/m2 (30 Min) Cohort 3 | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 60mg/m2 (60 Min) Cohort 4 | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 80mg/m2 (60 Min) Cohort 5 | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 100mg/m2 (60 Min) Cohort 6 | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Blood and lymphatic system disorders
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 60mg/m2 (30 Min) Cohort 1 | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 80mg/m2 (30 Min) Cohort 2 | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 100mg/m2 (30 Min) Cohort 3 | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 60mg/m2 (60 Min) Cohort 4 | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 80mg/m2 (60 Min) Cohort 5 | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 100mg/m2 (60 Min) Cohort 6 | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
General disorders and administration site conditions
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 60mg/m2 (30 Min) Cohort 1 | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 80mg/m2 (30 Min) Cohort 2 | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 100mg/m2 (30 Min) Cohort 3 | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 60mg/m2 (60 Min) Cohort 4 | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 80mg/m2 (60 Min) Cohort 5 | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 100mg/m2 (60 Min) Cohort 6 | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Nervous system disorders
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 60mg/m2 (30 Min) Cohort 1 | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 80mg/m2 (30 Min) Cohort 2 | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 100mg/m2 (30 Min) Cohort 3 | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 60mg/m2 (60 Min) Cohort 4 | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 80mg/m2 (60 Min) Cohort 5 | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 100mg/m2 (60 Min) Cohort 6 | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Skin and subcutaneous tissue disorders
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 60mg/m2 (30 Min) Cohort 1 | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 80mg/m2 (30 Min) Cohort 2 | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 100mg/m2 (30 Min) Cohort 3 | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 60mg/m2 (60 Min) Cohort 4 | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 80mg/m2 (60 Min) Cohort 5 | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 100mg/m2 (60 Min) Cohort 6 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Metabolism and nutrition disorders
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 60mg/m2 (30 Min) Cohort 1 | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 80mg/m2 (30 Min) Cohort 2 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 100mg/m2 (30 Min) Cohort 3 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 60mg/m2 (60 Min) Cohort 4 | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 80mg/m2 (60 Min) Cohort 5 | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 100mg/m2 (60 Min) Cohort 6 | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Injury, poisoning and procedural complications
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 60mg/m2 (30 Min) Cohort 1 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 80mg/m2 (30 Min) Cohort 2 | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 100mg/m2 (30 Min) Cohort 3 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 60mg/m2 (60 Min) Cohort 4 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 80mg/m2 (60 Min) Cohort 5 | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 100mg/m2 (60 Min) Cohort 6 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Respiratory, thoracic and mediastinal disorders
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 60mg/m2 (30 Min) Cohort 1 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 80mg/m2 (30 Min) Cohort 2 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 100mg/m2 (30 Min) Cohort 3 | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 60mg/m2 (60 Min) Cohort 4 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 80mg/m2 (60 Min) Cohort 5 | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 100mg/m2 (60 Min) Cohort 6 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Cardiac disorders
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 60mg/m2 (30 Min) Cohort 1 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 80mg/m2 (30 Min) Cohort 2 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 100mg/m2 (30 Min) Cohort 3 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 60mg/m2 (60 Min) Cohort 4 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 80mg/m2 (60 Min) Cohort 5 | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 100mg/m2 (60 Min) Cohort 6 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Musculoskeletal and connective tissue disorders
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 60mg/m2 (30 Min) Cohort 1 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 80mg/m2 (30 Min) Cohort 2 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 100mg/m2 (30 Min) Cohort 3 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 60mg/m2 (60 Min) Cohort 4 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 80mg/m2 (60 Min) Cohort 5 | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 100mg/m2 (60 Min) Cohort 6 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Vascular disorders
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 60mg/m2 (30 Min) Cohort 1 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 80mg/m2 (30 Min) Cohort 2 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 100mg/m2 (30 Min) Cohort 3 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 60mg/m2 (60 Min) Cohort 4 | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 80mg/m2 (60 Min) Cohort 5 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Phase 1 - 100mg/m2 (60 Min) Cohort 6 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 2
- title
- Investigations
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 8
- group Id
- OG005
- value
- 2
- title
- Gastrointestinal disorders
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 1
- title
- Blood and lymphatic system disorders
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 1
- title
- General disorders and administration site conditions
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 2
- title
- Nervous system disorders
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 0
- title
- Skin and subcutaneous tissue disorders
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 1
- title
- Metabolism and nutrition disorders
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 0
- title
- Injury, poisoning and procedural complications
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 0
- title
- Respiratory, thoracic and mediastinal disorders
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 0
- title
- Cardiac disorders
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 0
- title
- Musculoskeletal and connective tissue disorders
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- title
- Vascular disorders
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 8
- group Id
- OG005
- value
- 2
- units
- Participants
- description
- All TEAEs was reported from the first dose of study drug through the time of study drug discontinuation (at any time or Day 28 of the last treatment Cycle). All treatment-related TEAEs was followed until resolution or stabilization. For the purpose of regulatory reporting requirements, causal relationships of definite, probable, and possible was considered treatment-related.
Number of patients experiencing treatment-related adverse events (TEAE) as assessed by CTCAE v4.03. (June 2010).
- groups
- description
- Patients who received Tinostamustine at 60mg/m2 (30min) on D1 and D15 of a 4-week cycle
- id
- OG000
- title
- Tinostamustine (EDO-S101) - Phase 1 - 60mg/m2 (30 Min) Cohort 1
- description
- Patients who received Tinostamustine at 80mg/m2 (30min) on D1 and D15 of a 4-week cycle
- id
- OG001
- title
- Tinostamustine (EDO-S101) - Phase 1 - 80mg/m2 (30 Min) Cohort 2
- description
- Patients who received Tinostamustine at 100mg/m2 (30min) on D1 and D15 of a 4-week cycle
- id
- OG002
- title
- Tinostamustine (EDO-S101) - Phase 1 - 100mg/m2 (30 Min) Cohort 3
- description
- Patients who received Tinostamustine at 60mg/m2 (60min) on D1 and D15 of a 4-week cycle
- id
- OG003
- title
- Tinostamustine (EDO-S101) - Phase 1 - 60mg/m2 (60 Min) Cohort 4
- description
- Patients who received Tinostamustine at 80mg/m2 (60min) on D1 and D15 of a 4-week cycle
- id
- OG004
- title
- Tinostamustine (EDO-S101) - Phase 1 - 80mg/m2 (60 Min) Cohort 5
- description
- Patients who received Tinostamustine at 100mg/m2 (60min) on D1 and D15 of a 4-week cycle
- id
- OG005
- title
- Tinostamustine (EDO-S101) - Phase 1 - 100mg/m2 (60 Min) Cohort 6
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The safety analysis summarised TEAEs for all treated subjects using discrete summaries at the subject and event level by system organ class (SOC) and preferred term (PT). Treatment-related TEAEs were summarised similarly. TEAEs were also summarised by the grade of National Cancer Institute Common Terminology Criteria for Adverse Events. All AEs were coded using the MedDRA® version 24.0
- reporting Status
- POSTED
- time Frame
- From each patient's time of first dose administration to discontinuation of study drug (at any time or D28 of the last treatment cycle), up to 6 months.
- title
- Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE V4.03 on Phase 1
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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