NCT04988295 · ADVERSE EVENTS
Adverse events
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.
- Collection time frame
- From Cycle 1 Day 1 up to 1 year 7 months
- Other-event reporting threshold
- 5%
SAEs \& Other AEs:safety set-randomized participants who had at least 1 dose of study drug. All-cause mortality:FAS-all randomized participants, classified per assigned drug regardless of actual drug received. As per statistical analysis, Arm A AE planned to be collected and analyzed as single arm regardless of regimen LACP/ACP-L received. Since extension cohort is ongoing and its data collection and analysis was not planned for primary analysis, AE data will be reported after study completion.
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Main Study: Arm A: Lazertinib + Amivantamab + Carboplatin + Pemetrexed (LACP/ACP-L) | 137 / 263 | 261 / 263 | 69 / 263 |
| Main Study: Arm B: Carboplatin + Pemetrexed (CP) | 49 / 243 | 222 / 243 | 65 / 263 |
| Main Study: Arm C: Amivantamab + Carboplatin + Pemetrexed (ACP) | 42 / 130 | 129 / 130 | 27 / 131 |
Serious adverse events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA Version 25.0
- stats
- group Id
- EG000
- num Affected
- 6
- num At Risk
- 263
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 243
- group Id
- EG002
- num Affected
- 3
- num At Risk
- 130
- term
- Sepsis
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA Version 25.0
- stats
- group Id
- EG000
- num Affected
- 6
- num At Risk
- 263
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 243
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 130
- term
- Covid-19
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA Version 25.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 263
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 243
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 130
- term
- Skin Infection
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA Version 25.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 263
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 243
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 130
- term
- Gastroenteritis
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA Version 25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 263
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 243
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 130
- term
- Gastrointestinal Infection
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA Version 25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 263
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 243
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 130
- term
- Herpes Virus Infection
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA Version 25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 263
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 243
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 130
- term
- Infectious Pleural Effusion
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA Version 25.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 263
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 243
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 130
- term
- Neutropenic Sepsis
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA Version 25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 263
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 243
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 130
- term
- Pneumonia Viral
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA Version 25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 263
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 243
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 130
- term
- Soft Tissue Infection
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA Version 25.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 263
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 243
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 130
- term
- Bacteraemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA Version 25.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 263
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 243
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 130
- term
- Bacterial Infection
Other reported adverse events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 25.0
- stats
- group Id
- EG000
- num Affected
- 130
- num At Risk
- 263
- group Id
- EG001
- num Affected
- 90
- num At Risk
- 243
- group Id
- EG002
- num Affected
- 58
- num At Risk
- 130
- term
- Nausea
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 25.0
- stats
- group Id
- EG000
- num Affected
- 96
- num At Risk
- 263
- group Id
- EG001
- num Affected
- 72
- num At Risk
- 243
- group Id
- EG002
- num Affected
- 50
- num At Risk
- 130
- term
- Constipation
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 25.0
- stats
- group Id
- EG000
- num Affected
- 120
- num At Risk
- 263
- group Id
- EG001
- num Affected
- 21
- num At Risk
- 243
- group Id
- EG002
- num Affected
- 41
- num At Risk
- 130
- term
- Stomatitis
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 25.0
- stats
- group Id
- EG000
- num Affected
- 75
- num At Risk
- 263
- group Id
- EG001
- num Affected
- 42
- num At Risk
- 243
- group Id
- EG002
- num Affected
- 31
- num At Risk
- 130
- term
- Vomiting
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 25.0
- stats
- group Id
- EG000
- num Affected
- 66
- num At Risk
- 263
- group Id
- EG001
- num Affected
- 16
- num At Risk
- 243
- group Id
- EG002
- num Affected
- 17
- num At Risk
- 130
- term
- Diarrhoea
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 25.0
- stats
- group Id
- EG000
- num Affected
- 13
- num At Risk
- 263
- group Id
- EG001
- num Affected
- 6
- num At Risk
- 243
- group Id
- EG002
- num Affected
- 7
- num At Risk
- 130
- term
- Abdominal Pain
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 25.0
- stats
- group Id
- EG000
- num Affected
- 6
- num At Risk
- 263
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 243
- group Id
- EG002
- num Affected
- 7
- num At Risk
- 130
- term
- Dry Mouth
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 25.0
- stats
- group Id
- EG000
- num Affected
- 22
- num At Risk
- 263
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 243
- group Id
- EG002
- num Affected
- 7
- num At Risk
- 130
- term
- Haemorrhoids
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 25.0
- stats
- group Id
- EG000
- num Affected
- 173
- num At Risk
- 263
- group Id
- EG001
- num Affected
- 98
- num At Risk
- 243
- group Id
- EG002
- num Affected
- 73
- num At Risk
- 130
- term
- Neutropenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 25.0
- stats
- group Id
- EG000
- num Affected
- 156
- num At Risk
- 263
- group Id
- EG001
- num Affected
- 69
- num At Risk
- 243
- group Id
- EG002
- num Affected
- 57
- num At Risk
- 130
- term
- Thrombocytopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 25.0
- stats
- group Id
- EG000
- num Affected
- 141
- num At Risk
- 263
- group Id
- EG001
- num Affected
- 96
- num At Risk
- 243
- group Id
- EG002
- num Affected
- 50
- num At Risk
- 130
- term
- Anaemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 25.0
- stats
- group Id
- EG000
- num Affected
- 106
- num At Risk
- 263
- group Id
- EG001
- num Affected
- 67
- num At Risk
- 243
- group Id
- EG002
- num Affected
- 37
- num At Risk
- 130
- term
- Leukopenia
Complete source fields
- description
- SAEs \& Other AEs:safety set-randomized participants who had at least 1 dose of study drug. All-cause mortality:FAS-all randomized participants, classified per assigned drug regardless of actual drug received. As per statistical analysis, Arm A AE planned to be collected and analyzed as single arm regardless of regimen LACP/ACP-L received. Since extension cohort is ongoing and its data collection and analysis was not planned for primary analysis, AE data will be reported after study completion.
- event Groups
- deaths Num Affected
- 69
- deaths Num At Risk
- 263
- description
- LACP dosing (study start until 6 November 2022): Participants received Lazertinib 240 milligrams (mg) orally on Day 1 of each subsequent cycle, starting with Cycle 3, along with Amivantamab 1400 mg (1750 mg if body weight greater than or equal to \[\>=80\] kilograms \[kg\]) on Cycle 1 Days 1, 2, 8, and 15, and Cycle 2 Day 1 and 1750 mg (2100 mg if body weight \>=80 kg). Participant also received Pemetrexed 500 mg per square meter (mg/m\^2) on Day 1 21-day cycle, in combination with carboplatin 750 mg as IV infusion starting on Cycle 1 Day 1 for 4 cycles. From cycle 5 onwards, participants received Amivantamab, Pemetrexed and Lazertinib IV infusions at same dose, as maintenance until disease progression. ACP-L dosing (from 7 November 2022 until study completion): Participants received Amivantamab 1400 mg (1750 mg if body weight \>=80\] kg) on Cycle 1 Days 1,2, 8, and 15, and Cycle 2 Day 1 and 1750 mg (2100 mg if body weight \>=80 kg). Participant also received Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle, in combination with carboplatin 750 mg as IV infusion starting on Cycle 1 Day 1 for 4 cycles. Lazertinib 240 mg in ACP-L started on Cycle 5 Day 1 or sooner if carboplatin is discontinued before cycle 4. From cycle 5 onwards, participants received Amivantamab, Pemetrexed and Lazertinib IV infusions at same dose, as maintenance until disease progression. Each cycle consists of 21 days.
- id
- EG000
- other Num Affected
- 261
- other Num At Risk
- 263
- serious Num Affected
- 137
- serious Num At Risk
- 263
- title
- Main Study: Arm A: Lazertinib + Amivantamab + Carboplatin + Pemetrexed (LACP/ACP-L)
- deaths Num Affected
- 65
- deaths Num At Risk
- 263
- description
- Participants received Pemetrexed 500 mg/m\^2 IV infusion and carboplatin 750 mg IV infusion from Day 1 of Cycle 1 to 4. From cycle 5 onwards, participants received Pemetrexed 500 mg/m\^2 IV infusion, as maintenance until disease progression. Each cycle consists of 21 days.
- id
- EG001
- other Num Affected
- 222
- other Num At Risk
- 243
- serious Num Affected
- 49
- serious Num At Risk
- 243
- title
- Main Study: Arm B: Carboplatin + Pemetrexed (CP)
- deaths Num Affected
- 27
- deaths Num At Risk
- 131
- description
- Participants received Amivantamab 1400 mg (1750 mg if body weight \>=80 kg) on Cycle 1 Days 1,2, 8, and 15, and Cycle 2 Day 1 and 1750 mg (2100 mg if body weight \>=80 kg) on Day 1 of each cycle, starting with Cycle 3. Participants also received Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle, in combination with carboplatin 750 mg as IV infusion starting on Cycle 1 Day 1 for 4 cycles. From cycle 5 onwards, participants received Amivantamab and Pemetrexed IV infusions at same dose, as maintenance until disease progression. Each cycle consists of 21 days.
- id
- EG002
- other Num Affected
- 129
- other Num At Risk
- 130
- serious Num Affected
- 42
- serious Num At Risk
- 130
- title
- Main Study: Arm C: Amivantamab + Carboplatin + Pemetrexed (ACP)
- frequency Threshold
- 5
- other Events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 25.0
- stats
- group Id
- EG000
- num Affected
- 130
- num At Risk
- 263
- group Id
- EG001
- num Affected
- 90
- num At Risk
- 243
- group Id
- EG002
- num Affected
- 58
- num At Risk
- 130
- term
- Nausea
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 25.0
- stats
- group Id
- EG000
- num Affected
- 96
- num At Risk
- 263
- group Id
- EG001
- num Affected
- 72
- num At Risk
- 243
- group Id
- EG002
- num Affected
- 50
- num At Risk
- 130
- term
- Constipation
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 25.0
- stats
- group Id
- EG000
- num Affected
- 120
- num At Risk
- 263
- group Id
- EG001
- num Affected
- 21
- num At Risk
- 243
- group Id
- EG002
- num Affected
- 41
- num At Risk
- 130
- term
- Stomatitis
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 25.0
- stats
- group Id
- EG000
- num Affected
- 75
- num At Risk
- 263
- group Id
- EG001
- num Affected
- 42
- num At Risk
- 243
- group Id
- EG002
- num Affected
- 31
- num At Risk
- 130
- term
- Vomiting
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 25.0
- stats
- group Id
- EG000
- num Affected
- 66
- num At Risk
- 263
- group Id
- EG001
- num Affected
- 16
- num At Risk
- 243
- group Id
- EG002
- num Affected
- 17
- num At Risk
- 130
- term
- Diarrhoea
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 25.0
- stats
- group Id
- EG000
- num Affected
- 13
- num At Risk
- 263
- group Id
- EG001
- num Affected
- 6
- num At Risk
- 243
- group Id
- EG002
- num Affected
- 7
- num At Risk
- 130
- term
- Abdominal Pain
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 25.0
- stats
- group Id
- EG000
- num Affected
- 6
- num At Risk
- 263
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 243
- group Id
- EG002
- num Affected
- 7
- num At Risk
- 130
- term
- Dry Mouth
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 25.0
- stats
- group Id
- EG000
- num Affected
- 22
- num At Risk
- 263
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 243
- group Id
- EG002
- num Affected
- 7
- num At Risk
- 130
- term
- Haemorrhoids
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 25.0
- stats
- group Id
- EG000
- num Affected
- 173
- num At Risk
- 263
- group Id
- EG001
- num Affected
- 98
- num At Risk
- 243
- group Id
- EG002
- num Affected
- 73
- num At Risk
- 130
- term
- Neutropenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 25.0
- stats
- group Id
- EG000
- num Affected
- 156
- num At Risk
- 263
- group Id
- EG001
- num Affected
- 69
- num At Risk
- 243
- group Id
- EG002
- num Affected
- 57
- num At Risk
- 130
- term
- Thrombocytopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 25.0
- stats
- group Id
- EG000
- num Affected
- 141
- num At Risk
- 263
- group Id
- EG001
- num Affected
- 96
- num At Risk
- 243
- group Id
- EG002
- num Affected
- 50
- num At Risk
- 130
- term
- Anaemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 25.0
- stats
- group Id
- EG000
- num Affected
- 106
- num At Risk
- 263
- group Id
- EG001
- num Affected
- 67
- num At Risk
- 243
- group Id
- EG002
- num Affected
- 37
- num At Risk
- 130
- term
- Leukopenia
- serious Events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA Version 25.0
- stats
- group Id
- EG000
- num Affected
- 6
- num At Risk
- 263
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 243
- group Id
- EG002
- num Affected
- 3
- num At Risk
- 130
- term
- Sepsis
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA Version 25.0
- stats
- group Id
- EG000
- num Affected
- 6
- num At Risk
- 263
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 243
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 130
- term
- Covid-19
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA Version 25.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 263
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 243
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 130
- term
- Skin Infection
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA Version 25.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 263
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 243
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 130
- term
- Gastroenteritis
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA Version 25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 263
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 243
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 130
- term
- Gastrointestinal Infection
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA Version 25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 263
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 243
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 130
- term
- Herpes Virus Infection
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA Version 25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 263
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 243
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 130
- term
- Infectious Pleural Effusion
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA Version 25.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 263
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 243
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 130
- term
- Neutropenic Sepsis
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA Version 25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 263
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 243
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 130
- term
- Pneumonia Viral
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA Version 25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 263
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 243
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 130
- term
- Soft Tissue Infection
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA Version 25.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 263
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 243
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 130
- term
- Bacteraemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA Version 25.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 263
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 243
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 130
- term
- Bacterial Infection
- time Frame
- From Cycle 1 Day 1 up to 1 year 7 months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
Triangle