Special Drug Use Surveillance of Vonoprazan for "Maintenance Therapy of Reflux Esophagitis: Long-term Use"

An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug.

Endoscopic relapse rate was defined as a percentage of participants who met the criteria of Grade A to D in the modified Los Angeles (LA) classification. The modified LA classification graded endoscopic findings as follows- Grade N: normal mucosa; Grade M: minimal changes to the mucosa, such as erythema and/or whitish turbidity; Grade A: non-confluent mucosal breaks <5 mm in length; Grade B: nonconfluent mucosal breaks ≥ 5 mm in length; Grade C: confluent mucosal breaks <75% circumferential; Grade D: confluent mucosal breaks >=75% circumferential.

Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe heartburn at each time points were reported.

Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe acid reflux at each time points were reported.

Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe postprandial fullness at each time points were reported.

Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe early satiation at each time points were reported.

Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe epigastric pain at each time points were reported.

Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe epigastric burning at each time points were reported.

Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe abdominal bloating at each time points were reported.

Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe nausea/vomiting at each time points were reported.

Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe belching at each time points were reported.

Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe anorexia at each time points were reported.