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NCT04988295 · ADVERSE EVENTS

Adverse events

A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure · Source last updated 2026-08-20

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.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Main Study: Arm A: Lazertinib + Amivantamab + Carboplatin + Pemetrexed (LACP/ACP-L)

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.

137 / 263261 / 26369 / 263
Main Study: Arm B: Carboplatin + Pemetrexed (CP)

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.

49 / 243222 / 24365 / 263
Main Study: Arm C: Amivantamab + Carboplatin + Pemetrexed (ACP)

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.

42 / 130129 / 13027 / 131

Group identifiers: EG000: Main Study: Arm A: Lazertinib + Amivantamab + Carboplatin + Pemetrexed (LACP/ACP-L) · EG001: Main Study: Arm B: Carboplatin + Pemetrexed (CP) · EG002: Main Study: Arm C: Amivantamab + Carboplatin + Pemetrexed (ACP)

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 25.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      243
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      130
    term
    Sepsis
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 25.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      243
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      130
    term
    Covid-19
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      243
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      130
    term
    Skin Infection
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 25.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      243
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      130
    term
    Gastroenteritis
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      243
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      130
    term
    Gastrointestinal Infection
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      243
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      130
    term
    Herpes Virus Infection
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      243
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      130
    term
    Infectious Pleural Effusion
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 25.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      243
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      130
    term
    Neutropenic Sepsis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      243
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      130
    term
    Pneumonia Viral
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      243
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      130
    term
    Soft Tissue Infection
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      243
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      130
    term
    Bacteraemia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      243
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      130
    term
    Bacterial Infection

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 25.0
    stats
    1. group Id
      EG000
      num Affected
      130
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      90
      num At Risk
      243
    3. group Id
      EG002
      num Affected
      58
      num At Risk
      130
    term
    Nausea
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 25.0
    stats
    1. group Id
      EG000
      num Affected
      96
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      72
      num At Risk
      243
    3. group Id
      EG002
      num Affected
      50
      num At Risk
      130
    term
    Constipation
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 25.0
    stats
    1. group Id
      EG000
      num Affected
      120
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      243
    3. group Id
      EG002
      num Affected
      41
      num At Risk
      130
    term
    Stomatitis
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 25.0
    stats
    1. group Id
      EG000
      num Affected
      75
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      243
    3. group Id
      EG002
      num Affected
      31
      num At Risk
      130
    term
    Vomiting
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 25.0
    stats
    1. group Id
      EG000
      num Affected
      66
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      243
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      130
    term
    Diarrhoea
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 25.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      243
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      130
    term
    Abdominal Pain
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 25.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      243
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      130
    term
    Dry Mouth
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 25.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      243
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      130
    term
    Haemorrhoids
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 25.0
    stats
    1. group Id
      EG000
      num Affected
      173
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      98
      num At Risk
      243
    3. group Id
      EG002
      num Affected
      73
      num At Risk
      130
    term
    Neutropenia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 25.0
    stats
    1. group Id
      EG000
      num Affected
      156
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      69
      num At Risk
      243
    3. group Id
      EG002
      num Affected
      57
      num At Risk
      130
    term
    Thrombocytopenia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 25.0
    stats
    1. group Id
      EG000
      num Affected
      141
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      96
      num At Risk
      243
    3. group Id
      EG002
      num Affected
      50
      num At Risk
      130
    term
    Anaemia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 25.0
    stats
    1. group Id
      EG000
      num Affected
      106
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      67
      num At Risk
      243
    3. 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
  1. 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)
  2. 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)
  3. 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
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 25.0
    stats
    1. group Id
      EG000
      num Affected
      130
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      90
      num At Risk
      243
    3. group Id
      EG002
      num Affected
      58
      num At Risk
      130
    term
    Nausea
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 25.0
    stats
    1. group Id
      EG000
      num Affected
      96
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      72
      num At Risk
      243
    3. group Id
      EG002
      num Affected
      50
      num At Risk
      130
    term
    Constipation
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 25.0
    stats
    1. group Id
      EG000
      num Affected
      120
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      243
    3. group Id
      EG002
      num Affected
      41
      num At Risk
      130
    term
    Stomatitis
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 25.0
    stats
    1. group Id
      EG000
      num Affected
      75
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      243
    3. group Id
      EG002
      num Affected
      31
      num At Risk
      130
    term
    Vomiting
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 25.0
    stats
    1. group Id
      EG000
      num Affected
      66
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      243
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      130
    term
    Diarrhoea
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 25.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      243
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      130
    term
    Abdominal Pain
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 25.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      243
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      130
    term
    Dry Mouth
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 25.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      243
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      130
    term
    Haemorrhoids
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 25.0
    stats
    1. group Id
      EG000
      num Affected
      173
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      98
      num At Risk
      243
    3. group Id
      EG002
      num Affected
      73
      num At Risk
      130
    term
    Neutropenia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 25.0
    stats
    1. group Id
      EG000
      num Affected
      156
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      69
      num At Risk
      243
    3. group Id
      EG002
      num Affected
      57
      num At Risk
      130
    term
    Thrombocytopenia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 25.0
    stats
    1. group Id
      EG000
      num Affected
      141
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      96
      num At Risk
      243
    3. group Id
      EG002
      num Affected
      50
      num At Risk
      130
    term
    Anaemia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 25.0
    stats
    1. group Id
      EG000
      num Affected
      106
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      67
      num At Risk
      243
    3. group Id
      EG002
      num Affected
      37
      num At Risk
      130
    term
    Leukopenia
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 25.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      243
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      130
    term
    Sepsis
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 25.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      243
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      130
    term
    Covid-19
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      243
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      130
    term
    Skin Infection
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 25.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      243
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      130
    term
    Gastroenteritis
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      243
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      130
    term
    Gastrointestinal Infection
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      243
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      130
    term
    Herpes Virus Infection
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      243
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      130
    term
    Infectious Pleural Effusion
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 25.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      243
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      130
    term
    Neutropenic Sepsis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      243
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      130
    term
    Pneumonia Viral
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      243
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      130
    term
    Soft Tissue Infection
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      243
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      130
    term
    Bacteraemia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      243
    3. 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

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Preserved source evidence · Not medical advice