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NCT03989115 · ADVERSE EVENTS

Adverse events

Dose-Esc/Exp RMC4630 & Cobi in Relapsed/Refractory Solid Tumors & RMC4630& Osi in EGFR+ Locally Adv/Meta NSCLC · Source last updated 2023-06-26

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
AEs were collected from the start of intervention through 30 days post last day of study drug taken. Participants were monitored/assessed for adverse events for a maximum of 17 months which includes a maximum duration of 16 months on treatment.
Other-event reporting threshold
5%

Summary of serious treatment emergent adverse events in participants who received \> / = one dose of RMC-4630 and/or cobimetinib or in all participants who received \> / = one dose of RMC-4630 and/or osimertinib.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Intermittent RMC-4630 80mg (D1D4) + Cobimetinib 20mg QD (21/7)

Participants who received intermittent dose of RMC-4630 80 mg on D1 and D4 of a 28-day cycle and Cobimetinib 20 mg QD 21days on and 7 days off of a 28-day cycle

2 / 88 / 82 / 8
Intermittent RMC-4630 80mg (D1D4) + Cobimetinib 40mg QD (21/7)

Participants who received intermittent dose of RMC-4630 80mg on D1 and D4 of a 28-day cycle and Cobimetinib 40mg QD 21days on and 7 days off of a 28-day cycle

4 / 66 / 62 / 6
Intermittent RMC-4630 140mg (D1D4) + Cobimetinib 20mg QD (21/7)

Participants who received intermittent dose of RMC-4630 140 mg on D1 and D4 of a 28-day cycle and Cobimetinib 20mg QD 21days on and 7 days off of a 28-day cycle

3 / 1212 / 129 / 12
Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 20mg QD (21/7)

Participants who received intermittent dose of RMC-4630 140 mg on D1 and D2 of a 28-day cycle and Cobimetinib 20mg QD 21days on and 7 days off of a 28-day cycle

3 / 77 / 76 / 7
Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 40mg (D1D2)

Participants who received intermittent dose of RMC-4630 140 mg on D1 and D2 of a 28-day cycle and Cobimetinib 40mg D1 and D2 of a 28-day cycle

29 / 6564 / 6531 / 65
Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 60mg D1D2

Participants who received intermittent dose of RMC-4630 140 mg on D1 and D2 of a 28-day cycle and Cobimetinib 60mg D1 and D2 of a 28-day cycle

3 / 77 / 76 / 7
Intermittent RMC-4630 100mg (D1D2) + Osimertinib 80mg (QD)

Participants who received intermittent dose of RMC-4630 100 mg on D1 and D2 of a 28-day cycle and daily dose of Osimertinib 80 mg from D1 through D28 of a 28-day cycle

1 / 44 / 42 / 4
Intermittent RMC-4630 140mg (D1D2) + Osimertinib 80mg (QD)

Participants who received intermittent dose of RMC-4630 140 mg on D1 and D2 of a 28-day cycle and daily dose of Osimertinib 80 mg from D1 through D28 of a 28-day cycle

1 / 44 / 43 / 4

Group identifiers: EG000: Intermittent RMC-4630 80mg (D1D4) + Cobimetinib 20mg QD (21/7) · EG001: Intermittent RMC-4630 80mg (D1D4) + Cobimetinib 40mg QD (21/7) · EG002: Intermittent RMC-4630 140mg (D1D4) + Cobimetinib 20mg QD (21/7) · EG003: Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 20mg QD (21/7) · EG004: Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 40mg (D1D2) · EG005: Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 60mg D1D2 · EG006: Intermittent RMC-4630 100mg (D1D2) + Osimertinib 80mg (QD) · EG007: Intermittent RMC-4630 140mg (D1D2) + Osimertinib 80mg (QD)

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
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      65
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    gastrointestinal hemorrhage
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      65
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    term
    large intestinal obstruction
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      65
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    term
    small intestinal obstruction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      65
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    term
    vomiting
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      65
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    term
    abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      65
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      4
    term
    diarrhoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      65
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    term
    ileus paralytic
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      65
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    term
    intestinal obstruction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      65
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    term
    upper gastrointestinal haemorrhage
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      65
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    term
    pneumonia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      65
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    term
    sepsis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      65
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    term
    COVID-19 pneumonia

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
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      53
      num At Risk
      65
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      4
    term
    diarrhoea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      24
      num At Risk
      65
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    term
    nausea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      19
      num At Risk
      65
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      4
    term
    constipation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      13
      num At Risk
      65
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      4
    term
    vomiting
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      14
      num At Risk
      65
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    term
    abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      9
      num At Risk
      65
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    term
    abdominal distention
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      9
      num At Risk
      65
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      4
    term
    dry mouth
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      65
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    term
    ascites
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      23
      num At Risk
      65
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      4
    term
    fatigue
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      22
      num At Risk
      65
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      4
    term
    oedema peripheral
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      13
      num At Risk
      65
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    term
    pyrexia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      21
      num At Risk
      65
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      4
    term
    dyspnoea
Complete source fields
description
Summary of serious treatment emergent adverse events in participants who received \> / = one dose of RMC-4630 and/or cobimetinib or in all participants who received \> / = one dose of RMC-4630 and/or osimertinib.
event Groups
  1. deaths Num Affected
    2
    deaths Num At Risk
    8
    description
    Participants who received intermittent dose of RMC-4630 80 mg on D1 and D4 of a 28-day cycle and Cobimetinib 20 mg QD 21days on and 7 days off of a 28-day cycle
    id
    EG000
    other Num Affected
    8
    other Num At Risk
    8
    serious Num Affected
    2
    serious Num At Risk
    8
    title
    Intermittent RMC-4630 80mg (D1D4) + Cobimetinib 20mg QD (21/7)
  2. deaths Num Affected
    2
    deaths Num At Risk
    6
    description
    Participants who received intermittent dose of RMC-4630 80mg on D1 and D4 of a 28-day cycle and Cobimetinib 40mg QD 21days on and 7 days off of a 28-day cycle
    id
    EG001
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    4
    serious Num At Risk
    6
    title
    Intermittent RMC-4630 80mg (D1D4) + Cobimetinib 40mg QD (21/7)
  3. deaths Num Affected
    9
    deaths Num At Risk
    12
    description
    Participants who received intermittent dose of RMC-4630 140 mg on D1 and D4 of a 28-day cycle and Cobimetinib 20mg QD 21days on and 7 days off of a 28-day cycle
    id
    EG002
    other Num Affected
    12
    other Num At Risk
    12
    serious Num Affected
    3
    serious Num At Risk
    12
    title
    Intermittent RMC-4630 140mg (D1D4) + Cobimetinib 20mg QD (21/7)
  4. deaths Num Affected
    6
    deaths Num At Risk
    7
    description
    Participants who received intermittent dose of RMC-4630 140 mg on D1 and D2 of a 28-day cycle and Cobimetinib 20mg QD 21days on and 7 days off of a 28-day cycle
    id
    EG003
    other Num Affected
    7
    other Num At Risk
    7
    serious Num Affected
    3
    serious Num At Risk
    7
    title
    Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 20mg QD (21/7)
  5. deaths Num Affected
    31
    deaths Num At Risk
    65
    description
    Participants who received intermittent dose of RMC-4630 140 mg on D1 and D2 of a 28-day cycle and Cobimetinib 40mg D1 and D2 of a 28-day cycle
    id
    EG004
    other Num Affected
    64
    other Num At Risk
    65
    serious Num Affected
    29
    serious Num At Risk
    65
    title
    Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 40mg (D1D2)
  6. deaths Num Affected
    6
    deaths Num At Risk
    7
    description
    Participants who received intermittent dose of RMC-4630 140 mg on D1 and D2 of a 28-day cycle and Cobimetinib 60mg D1 and D2 of a 28-day cycle
    id
    EG005
    other Num Affected
    7
    other Num At Risk
    7
    serious Num Affected
    3
    serious Num At Risk
    7
    title
    Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 60mg D1D2
  7. deaths Num Affected
    2
    deaths Num At Risk
    4
    description
    Participants who received intermittent dose of RMC-4630 100 mg on D1 and D2 of a 28-day cycle and daily dose of Osimertinib 80 mg from D1 through D28 of a 28-day cycle
    id
    EG006
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    1
    serious Num At Risk
    4
    title
    Intermittent RMC-4630 100mg (D1D2) + Osimertinib 80mg (QD)
  8. deaths Num Affected
    3
    deaths Num At Risk
    4
    description
    Participants who received intermittent dose of RMC-4630 140 mg on D1 and D2 of a 28-day cycle and daily dose of Osimertinib 80 mg from D1 through D28 of a 28-day cycle
    id
    EG007
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    1
    serious Num At Risk
    4
    title
    Intermittent RMC-4630 140mg (D1D2) + Osimertinib 80mg (QD)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      53
      num At Risk
      65
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      4
    term
    diarrhoea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      24
      num At Risk
      65
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    term
    nausea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      19
      num At Risk
      65
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      4
    term
    constipation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      13
      num At Risk
      65
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      4
    term
    vomiting
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      14
      num At Risk
      65
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    term
    abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      9
      num At Risk
      65
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    term
    abdominal distention
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      9
      num At Risk
      65
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      4
    term
    dry mouth
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      65
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    term
    ascites
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      23
      num At Risk
      65
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      4
    term
    fatigue
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      22
      num At Risk
      65
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      4
    term
    oedema peripheral
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      13
      num At Risk
      65
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    term
    pyrexia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      21
      num At Risk
      65
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      4
    term
    dyspnoea
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      65
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    gastrointestinal hemorrhage
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      65
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    term
    large intestinal obstruction
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      65
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    term
    small intestinal obstruction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      65
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    term
    vomiting
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      65
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    term
    abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      65
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      4
    term
    diarrhoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      65
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    term
    ileus paralytic
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      65
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    term
    intestinal obstruction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      65
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    term
    upper gastrointestinal haemorrhage
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      65
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    term
    pneumonia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      65
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    term
    sepsis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      65
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    term
    COVID-19 pneumonia
time Frame
AEs were collected from the start of intervention through 30 days post last day of study drug taken. Participants were monitored/assessed for adverse events for a maximum of 17 months which includes a maximum duration of 16 months on treatment.

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Preserved source evidence · Not medical advice