Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 3:15 PM

Ignite Modification Date: 2025-12-25 @ 1:37 PM

NCT ID: NCT00404092

Description: None

Frequency Threshold: 5

Time Frame: None

Study: NCT00404092

Study Brief: Caspofungin Maximum Tolerated Dose in Patients With Invasive Aspergillosis

Event Groups(If Any):

Event Groups

Title	Description	Deaths # Affected	Deaths # At Risk	Serious # Affected	Serious # At Risk	Other # Affected	Other # At Risk	View

2nd Cohort	100mg 1x/day caspofungin : i.v.	None	None	5	8	8	8	View
3rd Cohort	150mg 1x/day caspofungin : i.v.	None	None	7	9	9	9	View
1st Cohort	70mg 1x/day caspofungin : i.v.	None	None	1	9	9	9	View
4th Cohort	200mg 1x/day caspofungin : i.v.	None	None	12	20	20	20	View

Serious Events(If Any):

Serious Events

Term	Type	Organ System	Vocab	View

Anemia	None	Blood and lymphatic system disorders	None	View
Psychosis	None	Psychiatric disorders	None	View
Enterocolitis	None	Gastrointestinal disorders	None	View
Bradycardia	None	Cardiac disorders	None	View
Hypotension	None	Blood and lymphatic system disorders	None	View
Syncope	None	Blood and lymphatic system disorders	None	View
Ventricular tachycardia	None	Cardiac disorders	None	View
Sepsis	None	Infections and infestations	None	View
Liver failure	None	Hepatobiliary disorders	None	View
Dyspnea	None	Respiratory, thoracic and mediastinal disorders	None	View
Hemoptysis	None	Respiratory, thoracic and mediastinal disorders	None	View
Pneumonia	None	Respiratory, thoracic and mediastinal disorders	None	View
Fever	None	General disorders	None	View
Lymphadenitis	None	Blood and lymphatic system disorders	None	View
Persistence or progression of underlying disease	None	General disorders	None	View
Pulmonary hemorrhage	None	Respiratory, thoracic and mediastinal disorders	None	View
Worsening of general condition	None	General disorders	None	View
Death	None	General disorders	None	View
Osteonecrosis	None	Musculoskeletal and connective tissue disorders	None	View
Urinary bladder tamponade	None	Surgical and medical procedures	None	View

Other Events(If Any):

Other Events

Term	Type	Organ System	Vocab	View

intermittant ear pressure	None	Ear and labyrinth disorders	None	View
pressure on the ears	None	Ear and labyrinth disorders	None	View
anemia	None	Blood and lymphatic system disorders	None	View
intermittend leukopenia	None	Blood and lymphatic system disorders	None	View
intermittend thrombocytopenia	None	Blood and lymphatic system disorders	None	View
leukopenia	None	Blood and lymphatic system disorders	None	View
neutropenia	None	Blood and lymphatic system disorders	None	View
persistence of blast cells	None	Blood and lymphatic system disorders	None	View
persistence of blasts	None	Blood and lymphatic system disorders	None	View
thrombopenia	None	Blood and lymphatic system disorders	None	View
arterial hypertension	None	Cardiac disorders	None	View
cardiac dysrrhthmias	None	Cardiac disorders	None	View
circulatory discomfort	None	Cardiac disorders	None	View
collaps	None	Cardiac disorders	None	View
cyanosis	None	Cardiac disorders	None	View
edema	None	Cardiac disorders	None	View
fall, knocked head	None	Cardiac disorders	None	View
heart-trouble	None	Cardiac disorders	None	View
hypertension	None	Cardiac disorders	None	View
hypotension	None	Cardiac disorders	None	View
hypotension with dizziness	None	Cardiac disorders	None	View
hypotonia	None	Cardiac disorders	None	View
tachycardia	None	Cardiac disorders	None	View
tightness in the chest	None	Cardiac disorders	None	View
vertigo	None	Cardiac disorders	None	View
thrombosis left leg	None	Vascular disorders	None	View
fatigue	None	General disorders	None	View
fatique	None	General disorders	None	View
loss of weight	None	General disorders	None	View
night sweat	None	General disorders	None	View
perspiration	None	General disorders	None	View
sweating	None	General disorders	None	View
weakness	None	General disorders	None	View
aching of the intravenuos line	None	Injury, poisoning and procedural complications	None	View
cavernoma left occipital cerebrum	None	Nervous system disorders	None	View
croakiness	None	Respiratory, thoracic and mediastinal disorders	None	View
dry nose	None	Respiratory, thoracic and mediastinal disorders	None	View
flu-like symptoms	None	Infections and infestations	None	View
frequent dejection	None	Gastrointestinal disorders	None	View
gain of weight	None	General disorders	None	View
haemorrhagic cystitis	None	Renal and urinary disorders	None	View
hair loss	None	General disorders	None	View
hardening of arm/leg	None	Musculoskeletal and connective tissue disorders	None	View
hearing loss	None	Ear and labyrinth disorders	None	View
high gammaglobuline/alpha-1-globuline	None	Hepatobiliary disorders	None	View
high LDH	None	Hepatobiliary disorders	None	View
decubitus ulcer both ears	None	Skin and subcutaneous tissue disorders	None	View
itching	None	Skin and subcutaneous tissue disorders	None	View
pruritus	None	Skin and subcutaneous tissue disorders	None	View
pruritus at the eyelids	None	Skin and subcutaneous tissue disorders	None	View
rash	None	Skin and subcutaneous tissue disorders	None	View
reddened hands	None	Skin and subcutaneous tissue disorders	None	View
redness at puncture	None	Skin and subcutaneous tissue disorders	None	View
redness of eyelid	None	Skin and subcutaneous tissue disorders	None	View
redness on backside	None	Skin and subcutaneous tissue disorders	None	View
swelling of arm/leg	None	Skin and subcutaneous tissue disorders	None	View
aphtha	None	Gastrointestinal disorders	None	View
brown coated tongue	None	Gastrointestinal disorders	None	View
coated tongue	None	Gastrointestinal disorders	None	View
constipation	None	Gastrointestinal disorders	None	View
diarrhea	None	Gastrointestinal disorders	None	View
discomfort over the liver area	None	Gastrointestinal disorders	None	View
dry lips	None	Gastrointestinal disorders	None	View
dry mucosa mouth	None	Gastrointestinal disorders	None	View
flatulence	None	Gastrointestinal disorders	None	View
heartburn	None	Gastrointestinal disorders	None	View
inappetance	None	Gastrointestinal disorders	None	View
inappetence	None	Gastrointestinal disorders	None	View
mucositis	None	Gastrointestinal disorders	None	View
nausea	None	Gastrointestinal disorders	None	View
obstipation	None	Gastrointestinal disorders	None	View
oral lesions due to dental prosthesis	None	Gastrointestinal disorders	None	View
pain during swallowing	None	Gastrointestinal disorders	None	View
red-brown coated tongue	None	Gastrointestinal disorders	None	View
sialorrhea	None	Gastrointestinal disorders	None	View
sore throat	None	Gastrointestinal disorders	None	View
swallow pain	None	Gastrointestinal disorders	None	View
vomiting	None	Gastrointestinal disorders	None	View
xerostomia	None	Gastrointestinal disorders	None	View
yellow coated tongue	None	Gastrointestinal disorders	None	View
bleeding at puncture	None	Injury, poisoning and procedural complications	None	View
bleeding operation wound left shoulder	None	Injury, poisoning and procedural complications	None	View
bloody sputum	None	Respiratory, thoracic and mediastinal disorders	None	View
haemoptysen	None	Respiratory, thoracic and mediastinal disorders	None	View
hematoma	None	Blood and lymphatic system disorders	None	View
hematoma at the neck	None	Blood and lymphatic system disorders	None	View
hematoma due to blood sampling	None	Injury, poisoning and procedural complications	None	View
hematoma left arm	None	Blood and lymphatic system disorders	None	View
hemoptysis	None	Respiratory, thoracic and mediastinal disorders	None	View
hemorrhoids bleeding	None	Gastrointestinal disorders	None	View
nosebleed	None	Blood and lymphatic system disorders	None	View
petechiae	None	Blood and lymphatic system disorders	None	View
red spots at the lower abdominal area	None	Blood and lymphatic system disorders	None	View
red spots, pustules	None	Blood and lymphatic system disorders	None	View
redness and bleeding of anus	None	Gastrointestinal disorders	None	View
urinary bleeding	None	Renal and urinary disorders	None	View
elevated bilirubin	None	Hepatobiliary disorders	None	View
elevated liver test (alt)	None	Hepatobiliary disorders	None	View
high ALT	None	Hepatobiliary disorders	None	View
high AP	None	Hepatobiliary disorders	None	View
high AST	None	Hepatobiliary disorders	None	View
high billirubin	None	Hepatobiliary disorders	None	View
high direct bilirubin	None	Hepatobiliary disorders	None	View
high gGT	None	Hepatobiliary disorders	None	View
high GPT	None	Hepatobiliary disorders	None	View
high total bilirubin	None	Hepatobiliary disorders	None	View
hyperbilirubinemia	None	Hepatobiliary disorders	None	View
intermittant elevated alt	None	Hepatobiliary disorders	None	View
low cholinesterase	None	Hepatobiliary disorders	None	View
low pancreas amylase	None	Hepatobiliary disorders	None	View
febrile neutropenia	None	Infections and infestations	None	View
fever	None	Infections and infestations	None	View
fever in neutropenia	None	Infections and infestations	None	View
herpes infection	None	Infections and infestations	None	View
herpes simplex infection lips	None	Infections and infestations	None	View
high procalcitonin	None	Infections and infestations	None	View
infection at the puncture of central ven	None	Infections and infestations	None	View
infection of puncture at central venous	None	Infections and infestations	None	View
infection with staphylococcus	None	Infections and infestations	None	View
infection with streptococcus mitis	None	Infections and infestations	None	View
klebsiella detection in sputum	None	Infections and infestations	None	View
rhinitis	None	Infections and infestations	None	View
swelling of the mucosa at the bottom of	None	Infections and infestations	None	View
thrombophlebitis	None	Infections and infestations	None	View
urethritis	None	Infections and infestations	None	View
urinary tract infection	None	Infections and infestations	None	View
alkaline phophatase increase	None	Hepatobiliary disorders	None	View
elevated uric acid	None	Renal and urinary disorders	None	View
high creatinine	None	Renal and urinary disorders	None	View
high urea	None	Renal and urinary disorders	None	View
high uric acid	None	Renal and urinary disorders	None	View
hypalbuminemia	None	Metabolism and nutrition disorders	None	View
hypercalcelmia	None	Metabolism and nutrition disorders	None	View
hyperchloridemia	None	Metabolism and nutrition disorders	None	View
hyperglykemia	None	Metabolism and nutrition disorders	None	View
hyperkalemia	None	Metabolism and nutrition disorders	None	View
hypernatremia	None	Metabolism and nutrition disorders	None	View
hyperuricemia	None	Renal and urinary disorders	None	View
hyperventilation	None	Respiratory, thoracic and mediastinal disorders	None	View
hypoalbuminemia	None	Metabolism and nutrition disorders	None	View
hypocalcemia	None	Metabolism and nutrition disorders	None	View
hypokalemia	None	Metabolism and nutrition disorders	None	View
hyponatremia	None	Metabolism and nutrition disorders	None	View
intermittant hypoalbuminia	None	Metabolism and nutrition disorders	None	View
intermittent hyponatremia	None	Metabolism and nutrition disorders	None	View
low albumin	None	Metabolism and nutrition disorders	None	View
confusion	None	Nervous system disorders	None	View
hallucination	None	Nervous system disorders	None	View
intermittant sleep disturbance	None	Nervous system disorders	None	View
intermittend sleeping disorder	None	Nervous system disorders	None	View
neuropathia aboth arms	None	Nervous system disorders	None	View
paraesthesia (fingers)	None	Nervous system disorders	None	View
paraesthesia (limbs, lips, fingers)	None	Nervous system disorders	None	View
patient not addressable	None	Nervous system disorders	None	View
prickle and numbness in both feet	None	Nervous system disorders	None	View
restlessness	None	Nervous system disorders	None	View
sleep disturbance	None	Nervous system disorders	None	View
slight drowsiness during caspofungin inf	None	Nervous system disorders	None	View
small pupils	None	Nervous system disorders	None	View
tremor	None	Nervous system disorders	None	View
viewing of colours	None	Nervous system disorders	None	View
worsening of visual acuity	None	Nervous system disorders	None	View
reddened eyes	None	Eye disorders	None	View
abdominal pain	None	Gastrointestinal disorders	None	View
ague	None	Infections and infestations	None	View
back pain	None	Musculoskeletal and connective tissue disorders	None	View
backache	None	Musculoskeletal and connective tissue disorders	None	View
bonepain	None	Musculoskeletal and connective tissue disorders	None	View
flank pain	None	General disorders	None	View
headache	None	Nervous system disorders	None	View
joint pain	None	Musculoskeletal and connective tissue disorders	None	View
kneepain	None	Musculoskeletal and connective tissue disorders	None	View
muscle pain	None	Musculoskeletal and connective tissue disorders	None	View
neck aches	None	Musculoskeletal and connective tissue disorders	None	View
neck ache	None	Musculoskeletal and connective tissue disorders	None	View
neck pain (osteoporosis)	None	Musculoskeletal and connective tissue disorders	None	View
neck stiffness	None	Musculoskeletal and connective tissue disorders	None	View
pain at puncture of the central venous c	None	Injury, poisoning and procedural complications	None	View
pain at the costal arch	None	Musculoskeletal and connective tissue disorders	None	View
pain in the left arm	None	Musculoskeletal and connective tissue disorders	None	View
pain in thorax and abdomen	None	Gastrointestinal disorders	None	View
pain left calf	None	Musculoskeletal and connective tissue disorders	None	View
pain left upper arm	None	Musculoskeletal and connective tissue disorders	None	View
pain on central venous catheder punction	None	Injury, poisoning and procedural complications	None	View
pain stomach left site	None	General disorders	None	View
painful peripheral catheter punktion pla	None	Injury, poisoning and procedural complications	None	View
painful shoulder	None	Musculoskeletal and connective tissue disorders	None	View
pressure pain on the fingernails	None	Skin and subcutaneous tissue disorders	None	View
slight backpain	None	Musculoskeletal and connective tissue disorders	None	View
thoracic pain	None	Respiratory, thoracic and mediastinal disorders	None	View
bronchospasms	None	Respiratory, thoracic and mediastinal disorders	None	View
cold	None	Respiratory, thoracic and mediastinal disorders	None	View
cough	None	Respiratory, thoracic and mediastinal disorders	None	View
cough, bloody sputum	None	Respiratory, thoracic and mediastinal disorders	None	View
dyspnea	None	Respiratory, thoracic and mediastinal disorders	None	View
hoarse voice	None	Respiratory, thoracic and mediastinal disorders	None	View
local pneumothorax	None	Respiratory, thoracic and mediastinal disorders	None	View
nasal discharge	None	Respiratory, thoracic and mediastinal disorders	None	View
pain int the lungs	None	Respiratory, thoracic and mediastinal disorders	None	View
pain while breathing	None	Respiratory, thoracic and mediastinal disorders	None	View
patients feels like he has a common cold	None	Respiratory, thoracic and mediastinal disorders	None	View
pleural effusion	None	Respiratory, thoracic and mediastinal disorders	None	View
stridor	None	Respiratory, thoracic and mediastinal disorders	None	View
worsening of breathing	None	Respiratory, thoracic and mediastinal disorders	None	View
yellow expectoration	None	Respiratory, thoracic and mediastinal disorders	None	View
acute renal failure	None	Renal and urinary disorders	None	View
pollakisuria	None	Renal and urinary disorders	None	View
polyuria	None	Renal and urinary disorders	None	View
reduced urine production	None	Renal and urinary disorders	None	View
low albumine	None	Metabolism and nutrition disorders	None	View
low protein	None	Metabolism and nutrition disorders	None	View
calf cramps	None	Musculoskeletal and connective tissue disorders	None	View
swelling of arm/leg	None	Musculoskeletal and connective tissue disorders	None	View
amentia	None	Psychiatric disorders	None	View