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NCT05198934 · ADVERSE EVENTS

Adverse events

Sotorasib and Panitumumab Versus Investigator's Choice for Participants With Kirsten Rat Sarcoma (KRAS) p.G12C Mutation · Source last updated 2026-07-22

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
All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
Other-event reporting threshold
5%

All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Trifluridine and Tipiracil or Regorafenib

Participants received investigator's choice of trifluridine and tipiracil or regorafenib. Treatment continued until progressive disease, intolerance to treatment necessitating treatment discontinuation, need for other anticancer therapy, withdrawal of consent, or death.

15 / 5148 / 5120 / 54
Sotorasib 240 mg + Panitumumab

Participants received sotorasib 240 mg QD in combination with panitumumab. Treatment continued until progressive disease, intolerance to treatment necessitating treatment discontinuation, need for other anticancer therapy, withdrawal of consent, or death.

17 / 5352 / 5318 / 53
Sotorasib 960 mg + Panitumumab

Participants received sotorasib 960 mg QD in combination with panitumumab. Treatment continued until progressive disease, intolerance to treatment necessitating treatment discontinuation, need for other anticancer therapy, withdrawal of consent, or death.

14 / 5352 / 5318 / 53

Group identifiers: EG000: Trifluridine and Tipiracil or Regorafenib · EG001: Sotorasib 240 mg + Panitumumab · EG002: Sotorasib 960 mg + Panitumumab

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
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      53
    term
    Cardiac arrest
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    term
    Cardiac failure acute
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    term
    Abdominal pain upper
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    term
    Ascites
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      53
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      53
    term
    Gastrointestinal haemorrhage
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    term
    Ileus
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    term
    Inguinal hernia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      53
    term
    Intestinal obstruction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    term
    Large intestinal obstruction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    term
    Small intestinal obstruction

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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      53
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      53
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      53
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      53
    term
    Abdominal pain upper
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      53
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      53
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      53
    term
    Dyspepsia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      53
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      53
    term
    Stomatitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      53
    term
    Vomiting
Complete source fields
description
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
event Groups
  1. deaths Num Affected
    20
    deaths Num At Risk
    54
    description
    Participants received investigator's choice of trifluridine and tipiracil or regorafenib. Treatment continued until progressive disease, intolerance to treatment necessitating treatment discontinuation, need for other anticancer therapy, withdrawal of consent, or death.
    id
    EG000
    other Num Affected
    48
    other Num At Risk
    51
    serious Num Affected
    15
    serious Num At Risk
    51
    title
    Trifluridine and Tipiracil or Regorafenib
  2. deaths Num Affected
    18
    deaths Num At Risk
    53
    description
    Participants received sotorasib 240 mg QD in combination with panitumumab. Treatment continued until progressive disease, intolerance to treatment necessitating treatment discontinuation, need for other anticancer therapy, withdrawal of consent, or death.
    id
    EG001
    other Num Affected
    52
    other Num At Risk
    53
    serious Num Affected
    17
    serious Num At Risk
    53
    title
    Sotorasib 240 mg + Panitumumab
  3. deaths Num Affected
    18
    deaths Num At Risk
    53
    description
    Participants received sotorasib 960 mg QD in combination with panitumumab. Treatment continued until progressive disease, intolerance to treatment necessitating treatment discontinuation, need for other anticancer therapy, withdrawal of consent, or death.
    id
    EG002
    other Num Affected
    52
    other Num At Risk
    53
    serious Num Affected
    14
    serious Num At Risk
    53
    title
    Sotorasib 960 mg + Panitumumab
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      53
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      53
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      53
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      53
    term
    Abdominal pain upper
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      53
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      53
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      53
    term
    Dyspepsia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      53
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      53
    term
    Stomatitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      53
    term
    Vomiting
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      53
    term
    Cardiac arrest
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    term
    Cardiac failure acute
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    term
    Abdominal pain upper
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    term
    Ascites
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      53
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      53
    term
    Gastrointestinal haemorrhage
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    term
    Ileus
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    term
    Inguinal hernia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      53
    term
    Intestinal obstruction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    term
    Large intestinal obstruction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    term
    Small intestinal obstruction
time Frame
All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.

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Preserved source evidence · Independent clinical review pending · Not medical advice